A Medical Device Daily

Cook Medical (Bloomington, Indiana) said it has completed enrollment in the first international clinical trial of a drug-eluting stent designed to treat arterial blockages outside the coronary arteries. The 420 patients enrolled in Cook's randomized trial of its Zilver PTX drug eluting peripheral stent include peripheral arterial disease (PAD) patients treated in Germany, the U.S. and Japan.

The Zilver PTX, a self-expanding nitinol stent, uses a polymer-free technology to coat the device with paclitaxel, an antiproliferative drug that has been used successfully to reduce the risk of renarrowing of arteries following angioplasty in coronary disease patients. Cook's ability to adhere the drug to the stent body without using a polymer may be a major clinical advantage, since it eliminates the risk some patients may face due to allergic reactions and other potentially poor outcomes that may be associated with the polymer coatings used on the current generation of drug-eluting coronary stents.

The Zilver PTX trial was designed to determine whether the combination of Cook's Zilver stent and a paclitaxel coating will keep peripheral arteries, specifically the superficial femoral artery (SFA), open over time.

"Completing enrollment in this international trial puts us ahead in the race to bring the benefits that drug-eluting stents have brought to millions of patients with coronary heart disease to the even greater number of patients suffering from peripheral arterial disease," said Rob Lyles, global leader of Cook Medical's peripheral intervention business unit. "Based on preliminary results, we anticipate that the Zilver PTX Stent will be found safe and effective by the world's medical regulatory bodies, and we expect to put this uniquely advanced medical therapy into the hands of the world's physicians in the near future."